We discuss the basics of research ethics, which have not changed following the revision of ethical guidelines; moreover, we discuss human resources training based on these basics. In the "Seven Requirements for Determining Whether a Research Trial Is Ethical" published in 2000, which both the past and the present guidelines refer to, the minimum requirements for research are: 1) it has social and academic value, and 2) scientific validity was consistent. Clinical research with social value is defined as "research that is intended to the patients' benefit" and "research that considers the patients' views". To ensure scientific validity, it is necessary to consider the study design. Prospective cohort studies should be considered to minimize bias. In the present study, we conducted a prospective cohort study of pregnant and nursing women, which aimed to identify predictable risk and protective factors for depression in the first postpartum month from pregnancy to the early postpartum using electronic signatures. In addition, we aimed to elucidate the pathogenesis of psychiatric disorders, which is the wish of patients and their families, and drug discovery based on pathogenesis, which has been promoted through multi-center collaboration and cooperation among various experts. Further progress in multi-center collaboration is expected with the revision of the guidelines. In addition, to realize genomic medicine for mental disorders using genome analysis, which is the starting point for elucidating pathophysiology, it is necessary to train psychiatrists who can provide genetic counseling, which is required by the ethical guidelines. Finally, we emphasize the importance of human resource development to clarify the pathogenesis of mental disorders, which is the wish of the patients and their families, with ethical consideration.
Author's abstract
Reconsidering the Basics of Research Ethics and Human Resource Development in the Context of Revised Ethical Guidelines
Nagoya University Graduate School of Medicine, Pathophysiology of Mental Disorders
Psychiatria et Neurologia Japonica
124: 487-495, 2022
<Keywords:research ethics, patient and family needs, elucidation of pathophysiology, genetic counseling, human resource development>